drugset / Trial / NCT01437748

Closing Volume Interpretation and Bronchodilators Effect

NCT01437748

RandomizedParallel-groupTriple-blindTreatment

Summary

* The gold standard measures to evaluate small airways (SAW) "in vivo" is not well understood * Two tests are today used to measure SAW but real results concordance is not clear * These problems have a small evidence * Data about real effect of bronchodilators on SAW (eg Tiotropium and Indacaterol) has never been studied * Only an acute bronchodilators effect, after one hour of drugs inhalation, will be evaluated * The time frame of study evaluations per patient will be of three hours: one hour for basal test; one hour rest after drug administration; one hour for post bronchodilators test * All enrolled subjects will be outpatients and will be evaluated after 24 hours of inhalatory drugs washout

Timeline

Start
2011-08
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Indacaterol Other / unclassified 300 ug Inhaled
Comparator Tiotropium Other / unclassified 18 ug Inhaled